The MISTIE III clinical trial, evaluating catheter-delivered thrombolysis for the treatment of intracerebral hemorrhage, is on track to complete enrollment in mid-2017. The 400th patient, out of 500 planned, was enrolled on 01-November!

Currently, there are 62 active sites which have screened over 15,000 subjects. There were 173 patients enrolled over the trailing twelve months, for an average of 14.4 patients randomized each month, albeit there is notable month-to-month variability with enrollment generally being higher in the winter months. Extrapolating, that suggests that enrollment should complete by June, which would be two months ahead of plan. Follow-up of the last enrolling patient should be complete 12 months later.

As of end-July 2016, we are at 356 enrollments (of 500). Over the trailing 12-month period (TTM), we have enrolled 178 subjects, an average of 14.8 per month. The number of actively-recruiting sites each month (activated less closures and temporary holds) is relatively stable at around 75 sites, and it seems likely that the current average enrollment rate will continue. Extrapolating, we are therefore on track to complete enrollment in around 10 months (May-2017), about 2 months ahead of plan. In our enrollment data, there is notable month-to-month variability, a possible seasonality effect, and a limited performance history with the later-starting ex-US sites that suggest a 2-month collar is reasonable (e.g., enrollment should complete in Mar-Jul period).

Enrollment at the Australia-Asia sites, managed by the George Institute (GI or TGI), is averaging around 0.75 randomizations per month (over the TTM period). At this rate, they will contribute around 20 to 24 subjects by enrollment completion.

Enrollment in the MTI substudy (across 23 of the M3 sites) is proceeding smoothly at approximately 4.3 subjects per month.At completion of enrollment in the overall trial, there should be approximately 90 subjects in this substudy (red line in the graph below).